Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06452615

Extracorporeal Shock Wave Therapy on Neuropathic Pain Post Mastectomy

PURPOSE: The main objective of the study is:

to evaluate the therapeutic effect of ESWT on intercostobrachial neuralgia post-mastectomy.

BACKGROUND:

Intercostobrachial neuralgia post-mastectomy is thought to develop from surgical damage to the intercostobrachial nerve, this nerve is injured in 80-100 % of mastectomy patients who undergo axillary lymph nodes dissection.

Pain that is localized in the axilla, medial upper arm, breast, and/or chest wall significantly affects the patient's mood, everyday activities, and social functioning, causing a heavy economic burden on healthcare systems. If poorly treated, patients may develop an immobilized arm, which can lead to severe lymphedema, frozen shoulder syndrome, and complex regional pain syndrome.

HYPOTHESES:

It will be hypothesized that:

Shock wave therapy has no effect in improving intercostobrachial neuralgia post-mastectomy.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Sixty female patients aged 40 and 65 years, suffering from intercostobrachial neuralgia after modified radical mastectomy will be selected from the National Cancer Institute, Cairo, Egypt. They will be randomly assigned into two equal groups, thirty patients each (study group and control group). The intervention in the study group will be conducted for 8 weeks.

Inclusive criteria :

The subject selection will be according to the following criteria:

  • The age range will be from 40 to 65 years.
  • All patients will be female patients suffering from intercostobrachial neuralgia after unilateral modified radical mastectomy.
  • All patients suffering from moderate or severe pain of burning, tingling, numbness, and electric nature persisting for 3-5 months following mastectomy, in the anterior chest wall, axilla, and upper medial arm with altered sensitivity of the skin in the painful area.
  • All patients had unilateral mild to moderate lymphedema (circumference difference 4 cm).
  • All patients will have completed their chemotherapy or radiotherapy treatment.
  • All patients enrolled in the study will have their informed consent.

Exclusive criteria:

Patients will be excluded from the study if they meet any of the following criteria:

  • Current metastases.
  • Continuing radiotherapy or chemotherapy.
  • History of allergy to coupling agent.
  • Chronic inflammatory diseases and cellulitis.
  • Venous thrombosis.
  • Local infections.
  • Patients with diabetes mellitus (neuritis).
  • Open skin lesions in the painful area.
  • Other causes of arm pain (brachial plexus neuropathy due to radiotherapy, cervical radiculopathy, peri-capsulitis of shoulder joint).

Outcomes:

  • ROM of the shoulder joint for flexion and extension
  • Level of pain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range will be from 40 to 65 years.
  • All patients will be female patients suffering from intercostobrachial neuralgia after unilateral modified radical mastectomy.
  • All patients suffering from moderate or severe pain of burning, tingling, numbness, and electric nature persisting for 3-5 months following mastectomy, in the anterior chest wall, axilla, upper medial arm with altered sensitivity of the skin in the painful area.
  • All patients had unilateral mild to moderate lymphedema (circumference difference 4 cm).
  • All patients will have completed their chemotherapy or radiotherapy treatment.
  • All patients enrolled to the study will have their informed consent.

Exclusion criteria

  • Current metastases.
  • Continuing radiotherapy or chemotherapy.
  • History of allergy to coupling agent.
  • Chronic inflammatory diseases and cellulitis.
  • Venous thrombosis.
  • Local infections.
  • Patients with diabetes mellitus (neuritis).
  • Open skin lesions in the painful area.
  • Other causes of arm pain (brachial plexus neuropathy due to radiotherapy, cervical radiculopathy, peri-capsulitis of shoulder joint).

Treatment and study plan

extracorporeal shockwave

Device

The patients will receive 3000 to 6000 pulses every session by a radius of 15 mm probe (R15) at a frequency of 10 Hz, with energy gradually increasing from 1.4 to 1.5 bar

Primary outcomes

  1. Neuropathic Pain

    Time frame: at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment).

    The Visual Analog Scale (VAS) will be used for assessing and quantifying pain exhibited by the patients.

  2. Range of Motion

    Time frame: Measurements will be taken at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment).

    Shoulder Flexion and Abduction will be assessed from supine position

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Extracorporeal Shock Wave Therapy on Intercostobrachial Neuralgia Post Mastectomy

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.